HDA Traceability Seminar Insights

Posted by bryan hanley On August 28, 2024 at 11:41 am | Comments Closed

Published August 28th, 2024

The 2024 HDA – Healthcare Distribution Alliance Traceability Seminar was an amazing opportunity for pharmaceutical industry leaders to discuss DSCSA compliance challenges, and present innovative solutions to help partners remediate these challenges. Below, we discuss some important HDA Traceability Seminar Insights. One of the major takeaways from the conference was the role of Waivers, Exceptions, and Exemptions (WEEs) on DSCSA deployments.

DSCSA Compliance Clock is Ticking

With the deadline for compliance approaching quickly, the compliance clock is ticking, and ticking fast; however, many appear unprepared. Despite reasonable efforts, many pharmaceutical supply chain partners are far from fully compliant, and likely won’t be by the time the stabilization period ends on November 27th.

The FDA has exempted small dispensers (25 or fewer full-time employees for the corporate entity owning the dispenser) from upcoming DSCSA electronic and data-driven requirements; these small dispensers account for about 1/3rd of total dispensers. What remains unclear is whether distributors who ship to these dispensers will also be exempt for those specific transactions.

Furthermore, the FDA cannot guarantee all of those who apply for WEEs will be answered by the end of the stabilization period, and the recommended deadline to submit these requests ended nearly a month ago.

The ambiguity over who is and who isn’t exempt and the indefiniteness of WEE approval could have detrimental implications on pharmaceutical supply chain integrity. Furthermore, handling common exceptions has proven difficult for big wholesalers and other partners, likely to further inhibit pharmaceutical supply chain security.

How Gateway Checker Can Help

The good news? Gateway Checker’s services provide wholesales, distributors, dispensers, and logistics providers the capabilities necessary to handle a variety of common exceptions, including:

  • Resending of a file with corrections (even after acceptance)
  • Reconciliation of partial shipments/short shipments
  • Digital instantiation of products with no corresponding EPCIS data (only to be used in accordance with SOPs)
  • Visibility into EPCIS errors

See for yourself how Gateway Checker simplifies DSCSA Compliance. Explore our features for yourself, or contact us to discuss your specific needs.

Gayr Lerner representing Gateway Checker at the 2024 HDA Traceability Seminar in Washington, DC.

TraceLink Attains Gateway Certified for GS1 US Pharmaceutical Traceability Scenarios

Posted by bryan hanley On August 27, 2024 at 12:47 pm | Comments Closed

Published August 27th, 2024

got tested?

Gateway Checker™, the leading provider of GS1 Certified Conformance Testing Services, applauds TraceLink’s recent attainment of GS1 US Conformance Trustmarks and Gateway Certified™ accreditation.

The Gateway Certified™ accreditation program provides independent, objective testing and conformance certification for entities seeking to comply with enhanced drug distribution security requirements. Such requirements are mandated under the FDA Drug Supply Chain Security Act (DSCSA).

Users of Gateway EPCIS Verify can automatically apply for a GS1 US Trustmark after fulfilling Pharmaceutical Traceability Scenario (PTS) requirements and earning a Gateway Certificate.

TraceLink, as the first solution provider to attain Gateway Certified for all 16 PTS use cases, demonstrates a commitment to GS1 Application Standards and DSCSA interoperability that is currently unmatched by its peers.

“Despite the necessity for alignment on information content and adherence to EPCIS application standards, it is our understanding that few other solution providers have demonstrated the confidence or commitment to subject their solutions to independent and impartial testing”, said Gary Lerner, President of Gateway Checker Corporation. “We encourage all solution providers, pharmaceutical manufacturers, and wholesalers interested in attaining DSCSA compliance and information interoperability to join the Gateway Certified™ program.”

Learn About the Gateway Certified Program

The GS1 US Rx EPCIS Conformance Testing Program ensures pharmaceutical supply chain integrity and facilitates information interoperability and compliance of data exchanges as mandated by DSCSA.

For a complimentary EPCIS and VRS conformance evaluation, get tested by an independent, certified testing service.

Be Confident, Get Certified.

 

Gateway Certified Seal, signaling accreditation attainment for GS1 US Pharmaceutical Traceability Scenarios

FDA Announces Small Dispenser Exemption

Posted by bryan hanley On July 12, 2024 at 5:38 pm | Comments Closed

On July 12th, 2024, the FDA announced an exemption for small dispensers from the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026.

However, the FDA will not extend further enforcement discretion for other parts of the supply chain.

Trading partners who are not prepared to meet the DSCSA’s enhanced traceability requirements by Nov. 27, 2024, are urged to seek individual waivers, exceptions, and exemptions (WEEs). However, the FDA has emphasized there’s no guarantee they will grant or deny these requests by the deadline, and the recommended deadline to submit these requests has already passed.

Furthermore, broad-scale WEEs could complicate DSCSA implementation and stabilization, particularly impacting those diligently preparing for interoperable traceability.

Gateway Checker is here to help you navigate these quickly approaching requirements. As the leading GS1 Conformance Testing Platform, Gateway Checker has a suite of services designed to help you protect the integrity of your supply chain and conform to necessary DSCSA Standards.

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How Ozempic Counterfeits Demonstrate the Urgent Need for a Secure Supply Chain

Posted by bryan hanley On March 8, 2024 at 11:30 am | Comments Closed

When demands soars for prescription pharmaceuticals and supply falls short, drug pirates get to work.

The bad actors manufacture and package fake drugs to look just like the legitimate brand-name medication. And many times, these counterfeits make their way into legitimate supply chains.

Counterfeit versions of Novo Nordisk’s diabetes drug Ozempic pose severe risks to patients worldwide, prompting CEO Lars Fruergaard Jorgensen to collaborate with authorities in various countries to address the issue.

Various reports reveal instances of patient harm, including dangerous drops in blood sugar, after consuming fake Ozempic, highlighting the urgent need for action.

Only a secure supply chain that is under constant surveillance can keep fraudulent drugs out of the legitimate supply chain. The FDA is protecting patients from adulterated or counterfeit medications through the Drug Supply Chain Security Act (DSCSA).

See how Gateway Checker can help you get there.

FDA Allows Florida to Import Prescription Drugs from Canada to Alleviate High Prices

Posted by bryan hanley On January 12, 2024 at 12:21 pm | Comments Closed

Florida marks a milestone as the FDA authorizes the state to import prescription drugs from Canada to alleviate high drug prices.

This decision, resulting from bipartisan discussions and executive orders, grants Florida a two-year period to implement its drug importation program, potentially saving the state up to $183 million in the first year.

However, obstacles remain, requiring Florida to fulfill additional FDA requirements, conduct quality testing, and address potential Canadian restrictions. The FDA’s approval is a political triumph, yet the program’s impact on overall drug prices for Floridians is uncertain.

Furthermore, what will the impact be on supply integrity? Will Canadian medications imported to the US be required to comply with the enhanced traceability requirements of DSCSA? What mechanisms will be implemented to ensure authenticity of the medication? With many domestic partners struggling to adhere, its interesting to see how Canadian entities will navigate this process.

Will other states explore similar strategies to combat high drug costs? What will happen to prices as demand shifts from domestic supply to Canada?